Physio-Anatomy Clinical Data Collection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HF-OCT Imaging, FFR Pressure Wire, Angiography.
- Who it may be relevant to
- Registry conditions: Coronary Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.
Detailed description
These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include:
* A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking. * Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters. * Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.
Interventions
- Device HF-OCT Imaging
Subjects undergo HF-OCT imaging of stenosed coronary arteries - Device FFR Pressure Wire
Subjects undergo FFR physiology assessment of stenosed coronary arteries - Device Angiography
Subjects undergo angiography imaging of stenosed coronary arteries
Primary outcome measures
- Collection of angiography images, HF-OCT images, and FFR pressure wire data [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Patients >18 years of age.
- Patients provide written informed consent.
- Clinical presentation consistent with suspected coronary disease.
- Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.
Exclusion criteria
- Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
- Contraindication for FFR examination or administration of vasodilators.
- Bacteremia or sepsis.
- Major coagulation system abnormalities.
- Severe hemodynamic instability or shock.
- Heart Failure NYHA Class IV.
- Severe valvular heart disease.
- Prior heart transplant.
- Acute renal failure based on diagnostic practice of the treating physician at time of screening.
- Patient is pregnant.
- Patient is currently enrolled in another clinical study that may impact the results of this study.
- Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United States · 6 centers
- Veteran's Administration Palo Alto — Palo Alto
- Tampa General Hospital — Tampa
- Atlanta VA Medical Center — Decatur
- Beth Israel Deaconess Medical Center — Boston
- Minneapolis VA Medical Center — Minneapolis
- The Christ Hospital — Cincinnati
Identifiers
NCT: NCT05312164 · 003785